Reported Aug 5, 2015 · Terminated
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA,…
Mutual Pharmaceutical Company, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mutual Pharmaceutical Company, Inc. · 1100 Orthodox St · Philadelphia, PA · 19124-3168
Is this the product you have?
- Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01
- Lot codes and dates
Lot #: 6676701 and 6676801exp 1/17
- Amount recalled
- 20,892 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
This product could cause temporary or reversible health problems — stop using it.
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